Senior Director, Process Chemistry

Location
San Diego, CA, United States
Posted
Jan 20, 2021
Ref
IurWTOHhao
Required Education
Doctorate/PHD/MD
Position Type
Full time
Vividion is a privately held biotechnology company based in San Diego that is leveraging an innovative and proprietary chemical proteomics platform to efficiently discover novel drugs in multiple areas including oncology and immunology. We aim to transform the future of human health through the limitless creation of highly selective small molecule medicines that reach unreachable targets. Vividion is looking for energetic and experienced candidates with a desire to work in a fast-paced and dynamic team environment. We believe that the whole team contributes to the overall mission. We succeed as a team, and we grow as a team.

Job Summary:

Reporting to the CSO, the Senior Director, Process Chemistry will be responsible for the process development and supply of small molecule drug substance (API) for all phases of clinical development (process research, scale-up, and process validation) and commercial launch activities. Note: exact title commensurate with experience.

Essential Duties and responsibilities:
  • Build, manage and lead a small internal team to work with CRO’s for scale-up and route optimization to deliver non-GMP and GMP material in multi-kilogram quantities
  • Develop overall API strategy, timelines, budgets, risk & mitigation plans for all process development and manufacturing campaigns
  • Design phase-appropriate synthetic routes and implement regulatory control strategies for GMP manufacture
  • Act as the technical subject matter expert (SME) internally for troubleshooting process chemistry issues
  • Work with project teams to identify drug substance requirements, manage and optimize aggressive project timelines, oversee the development of technical solutions to ensure that API processes can be successfully demonstrated and delivered
  • Author appropriate CMC sections to support regulatory (IND, IMPD, NDA) submissions
  • Represent Drug Substance Development in a cross-functional manner to provide assessments, evaluations, status, issues, and other relevant technical aspects of corresponding programs

Experience and education requirements:
  • Ph.D. with 12+ years industry experience in process chemistry in the biotechnology/pharmaceutical industry
  • Proven track record in developing and implementing robust and efficient drug substance manufacturing processes
  • Broad knowledge of regulatory and quality requirements for pharmaceutical products.

Required Key Attributes:
  • Effective troubleshooting and problem-solving skills
  • Excellent oral and written communication skills
  • Be an effective team player and strong individual contributor, flexible, and able to handle multiple tasks and deliver high quality results under tight timelines

Further Information:

In addition to a competitive compensation package with stock options, Vividion also offers a comprehensive benefits package for our employees and their families, which includes medical, dental, vision, life, disability insurance. Vividion Therapeutics, Inc. is an EEO employer.